W-CARE- allantoin gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)

Available from:

Lavior Inc.

INN (International Name):

ALLANTOIN

Composition:

ALLANTOIN 0.5 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

skin protectant - helps prevent and relieve dry, chafed, chapped, or cracked skin - temporarily protects minor cuts, scrapes, and burns - helps protect from the drying effects of wind and cold weather

Authorization status:

OTC monograph final

Summary of Product characteristics

W-CARE- ALLANTOIN GEL
LAVIOR INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
ACTIVE INGREDIENT:
Allantoin 0.5%..........................skin protectatant
PURPOS E:
skin protectant
US ES :
helps prevent and relieve dry, chafed, chapped, or cracked skin
temporarily protects minor cuts, scrapes, and burns
helps protect from the drying effects of wind and cold weather
WARNINGS :
FOR EXTERNAL USE ONLY
When using this product
avoid contact with eyes
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last more than 7 days or clear up and occur again within a
few days
DO NOT USE ON
deep or puncture wounds
animal bites
serious burns
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
apply a thin layer 1 to 2 times daily, or as directed by a doctor
OTHER INFORMATION
store at room temperature
INACTIVE INGREDIENTS:
Aqua, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Aloe
Barbadensis Leaf Juice, Xanthan Gum,
Sodium Benzoate, Potassium Sorbate, Citric Acid, Tocopheryl Acetate
(Vitamin E), Sodium
Hyaluronate
QUES TIONS ?
Call toll free 1844-474-2552 or visit www.lavior.com
W-CARE
allantoin gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:71521-8 76
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALLANTO IN (UNII: 344S277G0 Z) (ALLANTOIN - UNII:344S277G0 Z)
ALLANTOIN
0 .5 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)
HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)
.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
GLYCERIN (UNII: PDC6 A3C0 OX)
MALTO DEXTRIN (UNII: 7CVR7L4A2D)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
SO DIUM GLUCO NATE (UNII: R6 Q379 1S76 )
DITTRICHIA VISCO SA WHO LE (UNII: 3SYW6